In U.S. Pat. Nos. 4,744,364 and 4,852,568, assigned to the same assignee as this invention, there is disclosed a device for sealing an incision or puncture in tissue separating one portion of the body of a living being from another portion, e.g., a puncture in a blood vessel, duct or lumen, of a living being. Also disclosed are methods of use of that device. The device basically comprises an elongated tubular body having an outlet at its distal end. The distal end of the device is arranged to be inserted, such as percutaneously, through the puncture. In the case where the puncture is an artery or other blood vessel, the outlet is inserted through the puncture so that it is located within the blood vessel's interior. An expandable closure is disposed within the device's tubular body and is formed so that it is held in a compact or compressed configuration within the tubular body. The tubular body also includes an ejector in the form of a plunger-like member arranged to force the closure out of the outlet into the portion of the being's body contiguous with the opening, e.g., within the interior of the blood vessel, whereupon the closure automatically expands to form an enlarged tissue engagement surface.
A retraction filament is secured to the closure to enable it to be pulled fully into the puncture after the device's tubular body has been withdrawn so that the engagement surface of the closure intimately engages the inner surface of the tissue contiguous with the puncture.
In accordance with one aspect of the disclosure of those patents, the filament is held taut or otherwise secured and placed on the patient's skin to hold the closure in position in the puncture. Preferably, the closure and filament are each formed of some biodegradable material to enable them to be left in place. When the closure is used for sealing punctures or incisions in blood vessels it is constructed so that when it is open (i.e., in its expanded state) and in place sealing the puncture it doesn't appreciably block the flow of blood through the blood vessel.
In U.S. Pat. No. 4,890,612, assigned to the same assignee as this invention, there is disclosed a device for sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being and a method of use of that device. The device basically comprises a closure or plug formed of a material which when located within the puncture or incision expands automatically to engage the tissue contiguous therewith to seal the puncture and incision from the flow of body fluid therethrough. The closure disclosed in that application basically comprises a holding member, a filament, and a sealing member. The holding member is an elongated body, constructed like a toggle, and preferably formed of a biodegradable, thermoplastic polymer, such as polyglactide. The toggle is molded onto the distal end of the filament. The filament is also biodegradable, and preferably formed of polyglactide suture. The filament, being flexible, enables the toggle to pivot to various orientations with respect to it. The sealing member basically comprises a cylindrical plug, preferably formed of a compressed foam, which is highly absorbent and which when disposed within the body swells in excess of its compressed diameter.
The closure is arranged to be used by an instrument to place it within the puncture or incision to be sealed. The instrument includes a tubular member in which the closure is disposed so that the toggle is oriented with its longitudinal axis parallel to the longitudinal axis of the tubular member. When so disposed the toggle compresses the portion of the distal end of the sealing member. The filament extends backward from the toggle through the sealing member.
The instrument is introduced into the puncture or incision in the artery or any body tissue (e.g., the liver, gall bladder, lung, heart, etc.) until its outlet is at the desired position. In the case of sealing an artery, the outlet of the instrument is positioned so that it is within the artery. The instrument is then operated to expel the closure member from the tubular member. Once the closure is expelled, the instrument is held in this position for a short period of time to allow the foam at the tip of the closure, that is the distal end portion of the closure, to swell. This action effectively tilts the toggle. The instrument may then be withdrawn and the closure's filament retracted. This action pulls the closure's plug portion back through the puncture or incision in the artery wall until its toggle portion engages the inner surface of the artery wall to stop further retraction. As the toggle comes into engagement with the arterial wall, it effects the compression of the distal end portion of the sealing member. Moreover, the proximal end portion of the sealing member extends into the puncture or incision in the subcutaneous tissue to a point closely adjacent the skin. These actions effectively seal the puncture or incision from the passage of blood therethrough.
Other alternative embodiments of a plug or closure are also disclosed in U.S. Pat. No. 4,890,612. Those alternative embodiments basically comprise a preformed foam plug having an enlarged distal end portion serving as the holding member and a proximately located, rod-like portion serving as a sealing member. A retraction filament is secured to the sealing member. The closure is preferably formed of a dense collagen foam, with long collagen fiber reinforcements, so that it has a high expansion ratio (wet-to-dry) and good mechanical wet strength. Those alternative closures are also held within the instrument in a compressed state, with the holding portion located adjacent the instrument's outlet, and are inserted into the incision or puncture in the same manner as described heretofore. Once the closure is ejected out of the instrument, the holding portion of the closure swells upon contact with blood in the artery. The closure, now swollen, hangs up at the puncture or incision within the arterial wall, with the enlarged holding member portion engaging the inner surface of the interior wall and the sealing portion extending fully through the puncture or incision into the subcutaneous tissue. The filament is retracted to fully seat the closure in place so that the sealing portion extends fully through the puncture or incision in the arterial wall and with its proximal end located within the subcutaneous tissue closely adjacent the skin.
While the foregoing closures are generally suitable for their intended purposes, they still leave something to be desired from the standpoint of simplicity of construction and ease of use.